Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Closed-Loop With Faster Aspart in Young Adults With Type 1 Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03212950
Recruitment Status : Completed
First Posted : July 11, 2017
Last Update Posted : November 6, 2017
Sponsor:
Information provided by (Responsible Party):
University of Ljubljana, Faculty of Medicine

Brief Summary:

A randomized, double-blinded (for insulin type), single centre, crossover design young adult study, on 20 subjects with type 1 diabetes (T1D), aged 18 to 25 (inclusive) years, measuring time in glucose values within 3.9 - 10 mmol/l (70-180 mg/dl) under supervision of DreaMed Glucositter using either faster-acting insulin Aspart (Fiasp®, European Medicines Agency number EMEA/H/C/004046) or normal acting insulin Aspart.

Study duration will be about 3 weeks per subject, 5 month overall.

The objectives of this clinical investigation is:

1. to evaluate the safety and efficacy of blood glucose control using the DreaMed Glucositter with Fiasp® in young adults with T1D during and after unannounced afternoon physical activity and unannounced meals, in a controlled in-hospital environment.

Primary endpoint is significant between-group difference (intervention Fast-CL versus control Regular-CL) in time within range of glucose values within 3.9 - 10 mmol/l (70-180 mg/dl) during the unannounced afternoon exercise and unannounced standardized meals from 15:00 till 18:00 next day based on sensor glucose readings.


Condition or disease Intervention/treatment Phase
Type 1 Diabetes Mellitus Drug: Fast-CL Drug: Regular-CL Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Day and Night Closed-Loop Glycemic Control With Faster-Acting Insulin Aspart in Young Adults With Type 1 Diabetes Using DreaMed Glucositter - The Fast PHYSI-DREAM Study
Actual Study Start Date : July 10, 2017
Actual Primary Completion Date : November 1, 2017
Actual Study Completion Date : November 1, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
Experimental: Fast-CL
Glucose control using DreaMed Glucositter and Fiasp® (Fast-CL)
Drug: Fast-CL
After the admission we will insert new insulin (blinded) into the insulin pump. At 13:00 they will have lunch (with manual bolus). At 15:00 we will start CL control, participants/investigators will not be allowed to deliver manual bolus till the end of the study period. All meals and afternoon exercise (in the time between 16:30 and 19:30) will be unannounced and managed with CL.
Other Name: Faster Acting Insulin Aspart and DreaMed Glucositter

Active Comparator: Regular-CL
Glucose control using DreaMed Glucositter and regular insulin Aspart
Drug: Regular-CL
After the admission we will insert new insulin (blinded) into the insulin pump. At 13:00 they will have lunch (with manual bolus). At 15:00 we will start CL control, participants/investigators will not be allowed to deliver manual bolus till the end of the study period. All meals and afternoon exercise (in the time between 16:30 and 19:30) will be unannounced and managed with CL.
Other Name: Insulin Aspart and DreaMed Glucositer




Primary Outcome Measures :
  1. Time within range 3.9 - 10 mmol/l (70 - 180 mg/dl) [ Time Frame: 28 hours ]
    Primary endpoint is significant between-group difference (intervention Fast-CL versus control Regular-CL) in time within range 3.9 - 10 mmol/l (70 - 180 mg/dl) during the unannounced afternoon exercise and the afternoon/night after (till 18:00 next day) based on sensor glucose readings.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 25 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. The subject has documented T1D, as defined by the American Diabetes Association and World Health Organization (ADA/WHO) for at least 1 year prior to study enrolment
  2. Documented evidence should exist within the patient history of T1D
  3. The subject is between 18 and 25 years of age (inclusive) at the time of enrolment
  4. The subject has been treated with an insulin pump for at least 3 months
  5. The subject has an A1C value ≤ 9% based on analysis from the local laboratory at the time of enrolment

    ● A1C testing must follow National Glycohemoglobin Standardization Program (NGSP) standards.

  6. The subject is willing to follow all study instructions
  7. Subject is available for the entire study duration and follow-up visits
  8. Subject is willing to perform daily self-monitoring of blood glucose (SMBG) and required sensor calibrations
  9. If subject has celiac/Hashimoto disease, the disease has to be adequately treated as determined by the investigator
  10. Subject has a BMI above 5th centile and below 95th centile for age, respectively.

Exclusion Criteria:

  1. Concomitant diseases that influence metabolic control (e.g. anemia, significantly impaired hepatic function, renal failure, history of adrenal insufficiency) or other medical conditions, which in the investigator's opinion, may compromise patient safety; Note: Adequately treated thyroid disease and celiac disease do not exclude subjects from enrollment.
  2. Significant co-morbidity that, in the opinion of the investigators would preclude participation in the study (e.g. current treatment for cancer, mental disorder)
  3. Subject is taking or has taken oral or parenteral glucocorticoids within 1 month prior to screening, or plans to take oral or parenteral glucocorticoids during the study. Exceptions: Short term oral glucocorticoids up to 7 days, inhaled steroids.
  4. Subject is taking antidiabetic agents or other medications, which could be a contraindication to participation in the study by the judgment of the investigator.
  5. Subject is participating in another study of a medical device or drug that could affect glucose measurements or glucose management or Receipt of any investigational medical product within 1 month prior to screening (Visit 1).
  6. Female subject of child-bearing potential who is pregnant, breast-feeding, or planning to become pregnant during the study.
  7. Subject has a history of one or more episodes of Diabetic Ketoacidosis (DKA) requiring hospitalization within a month prior to the screening.
  8. Subject has current or recent history of alcohol or drug abuse.
  9. Subject has visual impairment or hearing loss, which in the investigator's opinion, may compromise patient ability to perform study procedures safely (child and parent should be evaluated as a unit).

    -


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03212950


Locations
Layout table for location information
Slovenia
UMC-University Children's Hospital
Ljubljana, Slovenia
Sponsors and Collaborators
University of Ljubljana, Faculty of Medicine
Investigators
Layout table for investigator information
Principal Investigator: Tadej Battelino, Prof, MD University of Ljubljana, Faculty of Medicine

Publications:

Layout table for additonal information
Responsible Party: University of Ljubljana, Faculty of Medicine
ClinicalTrials.gov Identifier: NCT03212950     History of Changes
Other Study ID Numbers: PD-FAST-01
First Posted: July 11, 2017    Key Record Dates
Last Update Posted: November 6, 2017
Last Verified: November 2017

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Insulin
Insulin, Globin Zinc
Insulin Aspart
Insulin, Long-Acting
Insulin degludec, insulin aspart drug combination
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Hypoglycemic Agents
Physiological Effects of Drugs